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ORIGINAL ARTICLE  VASCULAR SECTION 

The Journal of Cardiovascular Surgery 2017 October;58(5):650-7

DOI: 10.23736/S0021-9509.17.09305-3

Copyright © 2017 EDIZIONI MINERVA MEDICA

lingua: Inglese

The INNOVATION Trial: four-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System for endovascular repair

Giovanni PRATESI 1 , Carlo PRATESI 2, Roberto CHIESA 3, Gioacchino COPPI 4, Dierk SCHEINERT 5, Jan S. BRUNKWALL 6, Stefaan van der MEULEN 7, Giovanni TORSELLO 8, 9

1 Vascular Surgery Unit, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy; 2 Vascular Surgery Unit, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; 3 Department of Vascular Surgery, Faculty of Medicine, Vita-Salute San Raffaele University, Milan, Italy; 4 Department of Vascular Surgery, S. Agostino-Estense Hospital, University of Modena and Reggio Emilia, Baggiovara, Modena, Italy; 5 Department of Interventional Angiology, Faculty of Medicine, University of Leipzig, Leipzig, Germany; 6 Department of Vascular Surgery, Faculty of Medicine, University Clinic of Cologne, Cologne, Germany; 7 Syntactx Clinical Research Organization, New York, NY, USA; 8 St. Franziskus Hospital, Münster, Germany; 9 University Clinic of Münster, Münster, Germany


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BACKGROUND: This paper reports the 4-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System (Cordis Corp., Milpitas, CA, USA), an ultra-low-profile device for the treatment of abdominal aortic aneurysms.
METHODS: The INNOVATION Trial is the prospective, first-in-human, multicenter trial to evaluate the safety and effectiveness of the INCRAFT® System. Patients underwent annual clinical and computed tomography angiography examination as part of the study protocol. The INCRAFT® AAA Stent-Graft System is a customizable tri-modular design, with an ultra-low profile (14-Fr) delivery system. Patient were treated under approved protocol, the prescribed clinical and imaging follow-up at annually through 5 years. Results analyzed and adjudicated by a clinical events committee, independent core laboratory, and a data safety and monitoring board. This manuscript reports results through 4 years of follow-up.
RESULTS: A total of 60 patients were enrolled in the trial, all of whom were successfully treated. Follow-up rates at 1 and 4 years were 93% (56/60) and 85% (51/60), respectively. All-cause mortality at 4 years was 17.6% and no death was AAA-, device-, or procedure-related. The secondary reintervention rate at 1 year was 4.6%, primarily the result of stent thrombosis. In total, 10 patients required 13 post-procedure interventions within 4-years of follow-up (2 to repair a type I endoleak, 4 to repair a type II endoleak, 1 for stent thrombosis, 1 for renal stenosis, 1 for aneurysm enlargement, 2 for limb migration and 2 for prosthesis stenosis or occlusion). There were 4 cases (10%) of aneurysm enlargement reported at the 4 year follow-up. At 4 years, 38 out of 39 patients were free from type I and III endoleaks. There were no proximal type I or type III endoleaks at 4-year follow-up. Core laboratory evaluation of the postoperative imaging studies indicated absence of endograft migration while a single fracture was demonstrated without any clinical sequelae.
CONCLUSIONS: The INCRAFT® AAA Stent-Graft System provides a minimally invasive and durable solution for patients undergoing EVAR that has been associated with a low frequency of device-related events through 4 years of follow-up.


KEY WORDS: Abdominal aortic aneurysm - Endovascular procedures - Vascular grafting - Clinical trial

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